SARS-CoV-2 InfectionCovidSurg-3NCT05161299
CovidSurg-3: Outcomes of Surgery in COVID-19 Infection
An observational study of SARS-CoV-2 Infection and Surgery, run by University of Birmingham at 1 site in United Kingdom.
Trial summary
COVID-19 has significant detrimental impacts on surgical systems and patient outcomes. CovidSurg has provided the best available evidence to guide delivery of safe surgery during the pandemic. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- SARS-CoV-2 Infection, Surgery
- What is being tested?
- Surgery (across all specialities)
- Type of treatment
- Surgery or procedure
- How many people
- 2,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Dec 2021to 29 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients that underwent a surgical procedure during the patient inclusion period - 13 December 2021 to 28 February 2022 inclusive, regardless of surgical indication (benign surgery, cancer surgery, trauma, obstetric), anaesthetic type (local, regional, general), surgical approach (minimally invasive surgery, open surgery), or whether it is day-case or in-patient surgery
Who may be able to join
- Patients that underwent surgery performed by a surgeon in an operating theatre, AND
- They had a positive SARS-CoV-2 PCR swab or rapid antigen test (if PCR swab is not available) within 7 days before or 30 days after surgery. Patients can be included regardless of whether a specific variant is suspected or unknown
Who cannot join
- They underwent minor procedures
- Their SARS-CoV-2 infection was diagnosed more than 7 days before surgery (regardless of their symptomatic status at the time of surgery) or beyond 30 days after surgery
- All consecutive patients fulfilling inclusion criteria across all specialities should be captured.
Trial locations and contacts
1 site in 1 country.
Harvinder Mann contact
United Kingdom1 site
University of Birmingham
Birmingham
Dmitri Nepogodiev, D.Nepogodiev@bham.ac.uk
Aneel Bhangu
About this study
COVID-19 has significant detrimental impacts on surgical systems and patient outcomes. CovidSurg has provided the best available evidence to guide delivery of safe surgery during the pandemic. However, CovidSurg data were collected in 2020 when the wildtype SARS-CoV-2 virus was dominant, and therefore there is a need to for renewed rapid data to guide global practice during Omicron COVID-19 waves.
CovidSurg-3 is an extension to CovidSurg and was initiated in response to the emergence of the Omicron variant.
Read more
CovidSurg-3 has two separate components:
- Patient-level component: Collection of outcome data for patients with peri-operative SARS-CoV-2.
- Hospital-level component: Collection of aggregated case-mix data. Hospitals in countries with low community SARS-CoV-2 infection rates can contribute towards this component.
Read the detailed description
Data collected in 2020 found patients with perioperative SARS-CoV-2 infection to be at increased risk of postoperative mortality (up to 24% at 30-days), pulmonary complications (up to 51% at 30-days), and venous thromboembolism1-5. Perioperative SARS-CoV-2 infection has been associated with increased mortality, morbidity, longer length of stay, and increased health system burdens compared to SARS-CoV-2 negative patients6-8.
During the first COVID-19 wave, over 28 million elective operations worldwide were either cancelled or delayed9. This enabled redistribution of staff and resources to meet COVID-19 demand, but resulted in substantial treatment delays, including for cancer patients10-11. COVID-19 lockdowns were associated with one in seven patients awaiting cancer surgery not being operated, and those patients who were operated experienced delays10.
In 2020 CovidSurg captured outcomes on over 190,000 patients across >2,000 hospitals in 116 countries. This resulted in data-driven guidance for surgical systems during the pandemic, including:
- Guidance regarding the optimal delay prior to surgery following SARS-CoV-2 infection4.
- The establishment of COVID-19-free surgical pathways to reduce nosocomial infection and complication2.
- The non-effectiveness avoidance of preoperative isolation12.
- Optimal preoperative SARS-CoV-2 screening protocols13.
- Potential benefits of preoperative vaccination14.
The Omicron SARS-CoV-2 variant of concern was first reported on 25 November 2021 and has spread globally rapidly15. There is a high-level of evidence indicating Omicron has increased transmissibility and potential to evade immunity16-18. However, there is little robust evidence regarding disease severity associated with Omicron in both vaccinated and unvaccinated patients (including in surgical patients), nor is there data to guide patient risk stratification during Omicron COVID-19 waves18.
COVID-19 has significant detrimental impacts on surgical systems and patient outcomes. CovidSurg has provided the best available evidence to guide delivery of safe surgery during the pandemic. However, CovidSurg data were collected in 2020 when the wildtype SARS-CoV-2 virus was dominant, and therefore there is a need to for renewed rapid data to guide global practice during Omicron COVID-19 waves.
The primary objective is to determine 30-day mortality in patients with peri-operative SARS-CoV-2 infection. This will inform future risk stratification, decision making, and patient consent.
- Conditions
- SARS-CoV-2 Infection, Surgery
- Being tested
- Surgery (across all specialities)
- Keywords
- SARS-CoV-2, Surgery, Rapid Antigen test
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery (across all specialities)Procedure or surgery
Surgery performed by a surgeon in an operating theatre during the patient inclusion period
| Study group | Role | What they receive |
|---|---|---|
| Control (normal practice) | Patients that underwent surgery (across all specialities), performed by a surgeon in an operating theatre, AND had a positive SARS-CoV-2 PCR swab or rapid antigen test (if PCR swab is not available) within 7 days before or 30 days after surgery. Patients can be included regardless of whether a specific variant is suspected or unknown Receives: Procedure: Surgery (across all specialities) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine 30-day mortality in patients with peri-operative SARS-CoV-2 infection
Collection of outcome data (up to 30 days post-surgery) for patients with peri-operative SARS-CoV-2
Measured: Up to 30 days post-surgery
Secondary outcomes (4)
Rates of post-operative pulmonary complication and venous thromboembolism
To determine 30-day postoperative pulmonary complication and venous thromboembolism rates in patients with peri-operative SARS-CoV-2 infection
Measured: Up to 30 days post-surgery
Evaluate implementation of SARS-CoV-2 mitigations and adaptations (vaccination, preoperative testing, COVID-free surgical pathways, patient selection)
Data collected will help inform future risk stratification and decision making
Measured: Recruitment period (mid Dec 2021 - end Feb 2022)
Frequency of peri-operative SARS-CoV-2 infection
To determine the frequency of peri-operative SARS-CoV-2 infection by collecting aggregated case-mix data at a hospital-level over blocks of 7 consecutive days
Measured: 56 days
Frequency of same-day elective surgery cancellations
To determine the frequency of same-day elective surgery cancellations over blocks of 7 consecutive days
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start13 Dec 2021 (estimated)
- Primary completion28 Feb 2022 (estimated)
- Study completion29 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aneel Bhangu, Principal investigator, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05161299
- Sponsor's protocol ID
- CovidSurg-3
- Acronym
- CovidSurg-3
- Status last verified
- Dec 2021
- First submitted
- 16 Dec 2021
- Last updated
- 17 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CovidSurg-3: Outcomes of Surgery in COVID-19 Infection
- ClinicalTrials.gov ID
- NCT05161299
- Acronym / sponsor ID
- CovidSurg-3 / CovidSurg-3
- Conditions
- SARS-CoV-2 Infection, Surgery
- Keywords
- SARS-CoV-2, Surgery, Rapid Antigen test
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Study start
- 13 Dec 2021 (estimated)
- Primary completion
- 28 Feb 2022 (estimated)
- Study completion
- 29 Mar 2022 (estimated)
- First posted
- 17 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
COVID-19 has significant detrimental impacts on surgical systems and patient outcomes. CovidSurg has provided the best available evidence to guide delivery of safe surgery during the pandemic. However, CovidSurg data were collected in 2020 when the wildtype SARS-CoV-2 virus was dominant, and therefore there is a need to for renewed rapid data to guide global practice during Omicron COVID-19 waves.
CovidSurg-3 is an extension to CovidSurg and was initiated in response to the emergence of the Omicron variant.
CovidSurg-3 has two separate components:
- Patient-level component: Collection of outcome data for patients with peri-operative SARS-CoV-2.
- Hospital-level component: Collection of aggregated case-mix data. Hospitals in countries with low community SARS-CoV-2 infection rates can contribute towards this component.
Detailed description
Data collected in 2020 found patients with perioperative SARS-CoV-2 infection to be at increased risk of postoperative mortality (up to 24% at 30-days), pulmonary complications (up to 51% at 30-days), and venous thromboembolism1-5. Perioperative SARS-CoV-2 infection has been associated with increased mortality, morbidity, longer length of stay, and increased health system burdens compared to SARS-CoV-2 negative patients6-8.
During the first COVID-19 wave, over 28 million elective operations worldwide were either cancelled or delayed9. This enabled redistribution of staff and resources to meet COVID-19 demand, but resulted in substantial treatment delays, including for cancer patients10-11. COVID-19 lockdowns were associated with one in seven patients awaiting cancer surgery not being operated, and those patients who were operated experienced delays10.
In 2020 CovidSurg captured outcomes on over 190,000 patients across >2,000 hospitals in 116 countries. This resulted in data-driven guidance for surgical systems during the pandemic, including:
- Guidance regarding the optimal delay prior to surgery following SARS-CoV-2 infection4.
- The establishment of COVID-19-free surgical pathways to reduce nosocomial infection and complication2.
- The non-effectiveness avoidance of preoperative isolation12.
- Optimal preoperative SARS-CoV-2 screening protocols13.
- Potential benefits of preoperative vaccination14.
The Omicron SARS-CoV-2 variant of concern was first reported on 25 November 2021 and has spread globally rapidly15. There is a high-level of evidence indicating Omicron has increased transmissibility and potential to evade immunity16-18. However, there is little robust evidence regarding disease severity associated with Omicron in both vaccinated and unvaccinated patients (including in surgical patients), nor is there data to guide patient risk stratification during Omicron COVID-19 waves18.
COVID-19 has significant detrimental impacts on surgical systems and patient outcomes. CovidSurg has provided the best available evidence to guide delivery of safe surgery during the pandemic. However, CovidSurg data were collected in 2020 when the wildtype SARS-CoV-2 virus was dominant, and therefore there is a need to for renewed rapid data to guide global practice during Omicron COVID-19 waves.
The primary objective is to determine 30-day mortality in patients with peri-operative SARS-CoV-2 infection. This will inform future risk stratification, decision making, and patient consent.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Control (normal practice) | – | Procedure: Surgery (across all specialities)Patients that underwent surgery (across all specialities), performed by a surgeon in an operating theatre, AND had a positive SARS-CoV-2 PCR swab or rapid antigen test (if PCR swab is not available) within 7 days before or 30 days after surgery. Patients can be included regardless of whether a specific variant is suspected or unknown |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients that underwent a surgical procedure during the patient inclusion period - 13 December 2021 to 28 February 2022 inclusive, regardless of surgical indication (benign surgery, cancer surgery, trauma, obstetric), anaesthetic type (local, regional, general), surgical approach (minimally invasive surgery, open surgery), or whether it is day-case or in-patient surgery
Key inclusion criteria (2 listed)
- Patients that underwent surgery performed by a surgeon in an operating theatre, AND
- They had a positive SARS-CoV-2 PCR swab or rapid antigen test (if PCR swab is not available) within 7 days before or 30 days after surgery. Patients can be included regardless of whether a specific variant is suspected or unknown
Key exclusion criteria (3 listed)
- They underwent minor procedures
- Their SARS-CoV-2 infection was diagnosed more than 7 days before surgery (regardless of their symptomatic status at the time of surgery) or beyond 30 days after surgery
- All consecutive patients fulfilling inclusion criteria across all specialities should be captured.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgery (across all specialities)Surgery performed by a surgeon in an operating theatre during the patient inclusion period | Procedure or surgery | Control (normal practice) |
Primary outcome
To determine 30-day mortality in patients with peri-operative SARS-CoV-2 infection
Time frame: Up to 30 days post-surgery
Collection of outcome data (up to 30 days post-surgery) for patients with peri-operative SARS-CoV-2
4 secondary outcomes
Rates of post-operative pulmonary complication and venous thromboembolism
Time frame: Up to 30 days post-surgery
Evaluate implementation of SARS-CoV-2 mitigations and adaptations (vaccination, preoperative testing, COVID-free surgical pathways, patient selection)
Time frame: Recruitment period (mid Dec 2021 - end Feb 2022)
Frequency of peri-operative SARS-CoV-2 infection
Time frame: 56 days
Frequency of same-day elective surgery cancellations
Time frame: 56 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harvinder Mann contact
Aneel Bhangu principal investigator
University of Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV-2 Infection and Surgery, run by University of Birmingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dmitri Nepogodiev (+44 (0)121 6272949, D.Nepogodiev@bham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine 30-day mortality in patients with peri-operative SARS-CoV-2 infection (time frame: Up to 30 days post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2021.